Health Canada is pausing distribution of Johnson & Johnson vaccines after a recent inspection of a processing plant in Baltimore, Maryland, noted “multiple areas” of concern.
The federal agency said it learned that a drug substance produced at the site was used in the manufacturing of the initial Janssen vaccines received on April 28 and intended for use in Canada.
“The drug substance is the active ingredient that undergoes further processing before becoming the final product (i.e., the vaccine),” Health Canada said in a statement. “The final Janssen vaccines were manufactured at a different site located outside of the US.”
The Janssen vaccines “will only be released for distribution once Health Canada is satisfied that they meet the Department’s high standards for quality, safety and efficacy,” Health Canada said.
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In the meantime, the agency is working with Janssen and the FDA “to obtain all of the information it needs to complete this assessment, prior to releasing the Janssen vaccines for distribution. We will continue to ensure that products… will only be imported and distributed in Canada if they are of high quality and safe for use.”
As for the 1.5 million doses of AstraZeneca vaccine already imported into Canada from the same facility, Health Canada said it “remains confident” that this shipment meets the agency’s quality specifications.